Informed consent discussions need to be held with patients (and documented) for any treatment or procedure that has the potential for significant risk. This results in the patient’s educated decision either to pursue or refuse certain treatments or procedures. It lets the patient know that complications can and do occur even in the absence of negligence, and that all treatments involve some element of risk. While persons other than the physician may perform administrative tasks, such as obtaining the patient’s signature on a form, handing out an educational pamphlet or showing a video, it is the physician’s responsibility to complete the actual consent process. Any doubts about the necessity of obtaining a special consent from the patient should be resolved in favor of obtaining consent.

Where possible, it is desirable for the informed consent discussion to occur a sufficient period of time before the proposed treatment or procedure in order to allow the patient time to consider the information and ask questions. This also avoids any issue of pressure, duress or the influence of medications. During the discussion, you should use language the patient can understand and avoid the use of medical jargon.

The following information should be discussed with the patient and documented in the medical record:

1. The nature of the patient’s illness, the diagnosis, the proposed treatment plan and the prognosis.
2. A description of the recommended procedure or treatment and its purpose.
3. The probable outcome, particularly if it is difficult to predict, and the patient’s expected post-procedure/treatment course.
4. The most likely risks and side effects and the potential benefits, as well as the potential complications of the procedure or treatment.
5. Reasonable alternative methods of treatment or non-treatment including the risks, benefits, complications, and the prognosis associated with each alternative or with non-treatment.

A podiatry-specific informed consent can be found on PICA’s website.

Most states apply the “reasonable patient standard.” It focuses on what a patient would need to know in order to understand the decision he or she is being asked to make. A few states, Virginia for example, apply a “reasonable doctor standard.” This requires disclosure of the information a typical doctor would give about the treatment or procedure at issue.

The best approach to the question of how much information is enough is one that meets both your professional obligation to provide the best care and respects the patient as a person with the right to a voice in healthcare decisions. A physician need not disclose all of the risks or complications which may occur, but should discuss those risks most commonly associated with the procedure or treatment and which have a reasonable chance of occurring, as well as those risks which have a small chance of occurring but which have grave consequences.

Informed consent requires that a patient possess the requisite mental capacity to understand and weigh the positive and negative features of a proposed medical treatment and be able to voluntarily give or withhold consent after making an informed decision. If the issue of the patient’s capacity to consent is unclear, a psychiatric or other
consultation may be helpful. If the patient is determined not to have the capacity to make decisions, someone else must be authorized to make medical decisions and give consent for the patient. It may be someone holding a durable Power of Attorney for Healthcare, a court appointed guardian or other person authorized under state or other applicable law to act on behalf of the patient in making healthcare decisions, such as the next of kin.

In most situations, parents can give informed consent for treatment of their minor children. However, some states allow minors to play a more active role in their medical care and treatment, including informed consent. Many states have specific laws that allow minors to consent, without parental knowledge or approval, to healthcare treatments related to substance abuse, mental health and sexual activity. Likewise, many states make various exceptions for “mature minors” and “emancipated minors.”

It is important to be familiar with your individual state laws regarding appropriate informed consent procedures for incompetent individuals or minors.

If a patient lacks the capacity to provide consent, then the patient’s legal representative must provide consent. State laws usually specify the sequential order for identifying the legal representative if the patient has family members. Many times the patient does not have any living relatives. In such a case, a legal representative must be
named by the court. If a patient resides in a nursing home, the nursing home should have the name of the patient’s legal representative on file. If not, and the patient has no family, you are encouraged to work with the nursing home and/or an attorney to have a legal representative appointed for the patient.

One exception to the requirement for obtaining informed consent from a patient or the patient’s legal representation is the emergency exception. The emergency exception is generally defined as a situation in which immediate treatment is needed to save the patient’s life or health and for some reason consent cannot be obtained. There must be no indication that the patient would refuse the emergency treatment if he or she were able. In emergency cases, consent is considered to be implied. Although this exception is well established in both case law and legislation, it is important to carefully document the grounds for your conclusion that an emergency exists and your attempts to obtain consent. Once the patient has been stabilized, then continue your attempts to locate or obtain a legal representative.

There is no set period of time a signed consent form is valid. A period of 30 to 60 days is commonly used by healthcare organizations. Several factors should be considered when developing your office policy and procedure regarding consent forms.

Informed consent is a process of communication with the patient so that the patient is given enough information to make an informed decision to have or not to have a particular treatment or procedure. When a patient signs a consent form, he or she is attesting to the fact that the informed consent process took place. Some doctors utilize
the consent form as a guide for the informed consent discussion and ask the patient to sign the form at the end of the discussion. Other doctors have the informed consent discussion with the patient and ask the patient to sign the consent form at a later time. Either way, for elective procedures, the informed consent discussion should take place a sufficient amount of time prior to the planned treatment or procedure in order to give the patient time to think about the informed consent discussion, to ask questions and make an informed decision. Therefore, you would not want to restrict the period of time the form is considered valid to a short period of time such as one or two weeks.

However, you do not want too much time to pass after a patient signs a consent form. The patient’s condition may change, altering the planned procedure and/or the risks and benefits. If any element of informed consent (diagnosis, procedure, risks, benefits, etc.) changes after the patient signs a consent form, another informed consent discussion should take place and another form should be signed.

Also, if too much time passes, the patient may forget certain elements of the informed consent discussion. This may happen when elective surgery is scheduled, then cancelled for some reason, and rescheduled several months later. In this situation, it is prudent to review the informed consent discussion with the patient and have the patient re-sign and date the consent form if nothing has changed, or sign a new consent form, if needed.

Patients have the right to refuse treatment. If a patient refuses a recommended plan of treatment, it is important that you undergo and document an “informed refusal” discussion with the patient. This process is basically the same as for informed consent discussions.

The patient’s refusal may be due to a lack of understanding of the recommended treatment or the patient’s inability to comply with the plan of treatment for one reason or another. For example, the patient may be a single parent who cannot afford to take off work for several weeks. Therefore, patient education is crucial. Provide the patient
with specific, detailed information regarding the recommended treatment including the benefits and risks of the treatment and any risks connected with the failure to undergo the treatment. Additionally, discuss with the patient any alternative treatment possibilities and the risks and benefits of each. All discussions and educational efforts
should be documented in the patient’s medical record along with the fact that the patient was made aware and understands the risks of non-compliance with the recommended plan of treatment.

Documenting refusal of care is particularly important where the patient refuses care because of monetary considerations such as lack of Medicare coverage. It is crucial in those instances that the provider document that the patient took into consideration factors independent of his or her bank account by additionally weighing the medical risks at issue.

Ultimately, the decision whether to undergo a certain treatment remains at all times with the patient, regardless of the patient’s reasons for refusal. If the patient exhibits knowledge of the proposed procedure and the risks of refusal and still refuses, it is recommended that the practitioner ask the patient to sign a “refusal of treatment” form. In order to further reduce the practitioner’s liability in the event the patient suffers a poor outcome as a result of the non-compliance, the practitioner may consider terminating his/her relationship with the patient. (See section on “Physician-Patient Relationship.”)

A Refusal of Care form is available on PICA’s website.

As part of the informed consent process, the patient needs to be aware of who will be doing the surgery and provide consent for that person to perform surgery. If the patient refuses to consent to surgery by a resident, and the resident performs the surgery anyway, or if the surgery is performed by a resident without the patient’s prior knowledge and consent, a claim for battery might arise. This could also be a factor in a claim for failure to obtain informed consent since it could be argued that whether or not a resident would be performing the surgery could be a major factor in the patient’s decision to have or not have surgery.

The informed consent discussion with the patient should be held by the doctor who will actually perform the surgery, and that doctor’s name should be listed on the consent form as the doctor who will be performing the surgery, along with the fact that residents may assist.